Automated testing of embedded systems in medical device development

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1 Automated testing of embedded systems in medical device development MedConf 2011 Munich 06 Oct 2011 Mechatronic AG Thomas Jetter & Sven Rippel MedConf Munich, 06 Oct

2 Mechatronic AG Founded in Employees Industry: Medical devices Business activities: System development Hardware development Software development Production Engineering Manufacturing Höhn (Subsidiary) Darmstadt (Head office) MedConf Munich, 06 Oct

3 Automated testing of embedded systems in medical device development Agenda 1. Introduction 2. Initial considerations 3. Conception 4. Realization 5. Application example 6. Verification / Validation 7. Summary and perspective MedConf Munich, 06 Oct

4 Why use automated testing? Generate unambiguous test cases Repeat test execution with minimal efforts Ensure reproducible test results Achieve high test coverage Improve efficiency during development (find defects early) Implement and use stress testing already during design MedConf Munich, 06 Oct

5 Terms and definitions Levels of software testing Unit testing Single, isolated software module Integration testing Sub set of integrated software components System testing Fully integrated software system on target platform MedConf Munich, 06 Oct

6 Terms and definitions SiL (Software in the Loop) Software module (under test) Simulated software (stubs, mocks) SW interfaces MedConf Munich, 06 Oct

7 Terms and definitions HiL (Hardware in the Loop) Embedded device (under test) Simulated hardware (sensors, actors) Electrical interfaces MedConf Munich, 06 Oct

8 Terms and definitions EiL (Environment in the Loop) Embedded device (under test) With sensors and actors Simulated environment (forces, temperature, ) Physical interfaces MedConf Munich, 06 Oct

9 Automated testing of embedded systems in medical device development Agenda 1. Introduction 2. Initial considerations 3. Conception 4. Realization 5. Application example 6. Verification / Validation 7. Summary and perspective MedConf Munich, 06 Oct

10 Core requirements System testing on target platform (SiL, HiL, EiL) Cross-project automation approach Good integration with external hardware Simple, comprehensible scripts Flexible document generation Adaptable to internal processes MedConf Munich, 06 Oct

11 Core requirements Why test on the target? Timing critical sequences Interrupt-Handling Compiler errors Memory overflows Integration with hardware MedConf Munich, 06 Oct

12 Demarcation Not for unit level testing Not for production testing MedConf Munich, 06 Oct

13 Market analysis Many tools with SiL approach Relatively simple to implement All-purpose Often strong focus on unit level testing HiL/EiL approach under represented Requirements are too diverse External hardware is a must Conclusion: Proprietary development MedConf Munich, 06 Oct

14 Additional challenges with in-house development Budgeting (own development project) Time lines (delayed availability) Sound system concept MedConf Munich, 06 Oct

15 Automated testing of embedded systems in medical device development Agenda 1. Introduction 2. Initial considerations 3. Conception 4. Realization 5. Application example 6. Verification / Validation 7. Summary and perspective MedConf Munich, 06 Oct

16 Basic concept Feedback, Measurement results Test framework? Device Under Test (DUT) Software Under Test Stimulation, hardware simulation MedConf Munich, 06 Oct

17 Solution Test Framework Device Under Test Software -Interfaces Hardware/Phys. -Interfaces MedConf Munich, 06 Oct

18 Detailed concept Test Project Requirements Assets Test Case Scripts Use Case Scripts Test Tool Editor Compiler / Interpreter DUT Report Generator (SW Plug-In) Target Interface DLLs External hardware equipment MedConf Munich, 06 Oct

19 Automated testing of embedded systems in medical device development Agenda 1. Introduction 2. Initial considerations 3. Conception 4. Realization 5. Application example 6. Verification / Validation 7. Summary and perspective MedConf Munich, 06 Oct

20 Scripts Requirements for scripts Comprehensible and simple to review Direct editing in the tool, no external editor (usability) Access to reference data (assets) Adding attachments to report at run time Mandatory pass/fail decision Textual test description (for protocol and report) MedConf Munich, 06 Oct

21 Scripts Simplification of scripts Outsource complexity as far as possible: Target Interface Libraries Use Case scripts Abandonment of language constructs which are difficult to comprehend (e.g. lambda expressions, linq, delegates, events) MedConf Munich, 06 Oct

22 Scripts bool Run() { var currents_ua = new double[] {12.5, 14.8}; foreach(var referencecurrent in currents_ua) { USECASE.ApplyCurrent(referenceCurrent); } } var measuredcurrent = TARGET.MeasureCurrent(); ATTACH(referenceCurrent, ReferenceCurrent [µa] ); ATTACH(measuredCurrent, MeasuredCurrent [µa] ); if (measuredcurrent!= referencecurrent) { return FAIL; } return PASS; Tolerance limits by operator overloading MedConf Munich, 06 Oct

23 Interface DUT Target Interface Dispatcher View Integration layer Model Driver Physical interface Target Interface MedConf Munich, 06 Oct

24 Test execution Test execution from within the tool Definable set of test cases to be executed Storage of results in a file Report generation on bases of these data MedConf Munich, 06 Oct

25 Requirements for report generator Different formats, e.g. WORD and HTML Use of templates Protocol and report generation for approval Trace matrices Test summary MedConf Munich, 06 Oct

26 Requirements for report generator Test case single view Pass/Fail information Textual description Traces to requirements Visualization of attachments MedConf Munich, 06 Oct

27 Automated testing of embedded systems in medical device development Agenda 1. Introduction 2. Initial considerations 3. Conception 4. Realization 5. Application example 6. Verification / Validation 7. Summary and perspective MedConf Munich, 06 Oct

28 The product Mobile in-vitro diagnostic device Part of a device family Approx pcs. p.a. 32 Bit µc New measurement technology MedConf Munich, 06 Oct

29 Surrounding conditions Communication interface and protocol pre-set by customer (device family) Software built on basis of existing code Many manual test cases for device family existing and reusable Testing focused on new measurement algorithms Implementation of measurement algorithms optimized for automated testing in final system MedConf Munich, 06 Oct

30 Characteristics of algorithms under test Measurement transients consist of several hundred data points Complex calculations using floating point math Timing critical, interrupt driven Extensive error detection mechanisms Temperature compensation MedConf Munich, 06 Oct

31 Integration into the framework Test framework Target Interface (USB interface) Integration layer Measurement algorithms... Measurement hardware / drivers DUT Signal generator (voltage source) MedConf Munich, 06 Oct

32 Software architecture Test framework (Integration layer) Timer (interrupt) Algorithm core Access layer Analog frontend (interrupt) Algorithm calculations Transient buffer MedConf Munich, 06 Oct

33 Core functions of the Target Interface Reading and writing of measurement transients Injection of simulated temperature values Triggering of measurement runs Diverse implementation of algorithms in 128 Bit floating point Complex comparison operators Manipulation of transients MedConf Munich, 06 Oct

34 Gained Experience Permutations: approx in 12 hours Proof of stability established early and repetitively Script creation < 1 week Creation of target interface: approx. 1 month Minimal efforts for additional devices of same product family MedConf Munich, 06 Oct

35 Automated testing of embedded systems in medical device development Agenda 1. Introduction 2. Initial considerations 3. Conception 4. Realization 5. Application example 6. Verification / Validation 7. Summary and perspective MedConf Munich, 06 Oct

36 Test tool in general Focus on core functionalities Editor Compiler Test Execution Report Provider Tracing MedConf Munich, 06 Oct

37 Project context Target Interface Test scripts Manual test plan if applicable Review Scripts and assets Review Libraries Test scripts Unit test and review MedConf Munich, 06 Oct

38 Screen shots Context sensitive toolbar Project explorer Property explorer Document section MedConf Munich, 06 Oct

39 Automated testing of embedded systems in medical device development Agenda 1. Introduction 2. Initial considerations 3. Conception 4. Realization 5. Application example 6. Verification / Validation 7. Summary and perspective MedConf Munich, 06 Oct

40 Summary and perspective Enhancements test tool: Descriptions as RTF Multi user capabilities Integrated configuration management Expand plug-in approach Improve usability Code base (embedded) Generic event interfaces MedConf Munich, 06 Oct

41 Conclusion Expected advantages confirmed Flexible mixing of SiL, HiL and EiL possible Testing approach fully scalable Tool established cross projects Good decision! MedConf Munich, 06 Oct

42 MedConf Munich, 06 Oct

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